The invention generally relates to the field of otoscopy and in particular to an improved otoscopic tip element for use with otoscopic apparatus.
Ear infections are the leading cause of hearing loss and most common reason for surgery in children. They are responsible for 30M visits to physicians each year in the U.S. and represent a nearly $10 B burden on the U.S. economy. The American Academy of Pediatrics (AAP) and the American Academy of Otolaryngology (AAO) recommend pneumatic otoscopy as the gold standard for diagnosing this disease, wherein a change in pressure is delivered to the ear canal to modulate the eardrum; however, very few physicians perform the exam correctly due to difficulty establishing a seal of the ear canal.
The current gold standard for diagnosing middle ear infections is otoscopy, where a lens is used to visually examine the surface of the tympanic membrane (TM), or eardrum. However, this exam is highly subjective, with misdiagnosis rates of up to 50% amongst typical physicians. The addition of pneumatic otoscopy to the standard exam can increase the accuracy of the exam to 90%, and is part of the recommended guidelines developed by the American Academy of Pediatrics (AAP) and the American Academy of Otolaryngology (AAO). Pneumatic otoscopy, or the use of a traditional otoscope supplemented with an insufflation bulb, allows the physician to control the pressure in the ear canal to induce deflections of the TM. A physician then observes the deflection behavior of the TM to deduce the presence or absence of an effusion in the middle ear. However, this additional exam is rarely performed correctly because it is very difficult to obtain a sufficient seal of the ear canal using the current otoscope and speculum technology on the market.
Current disposable specula make it difficult to obtain a seal of the ear canal, and even products designed for pneumatic use perform very poorly due to the use of hard rubber material and non-ideal geometry. Currently, the most commonly used specula are standard tips in 4.2 mm (adult) or 2.7 mm (pediatric) sizes. While these tips are good for interfacing with the ear canal and provide access to a surface image of the TM, they are not designed specifically to facilitate sealing of the ear canal for pneumatic otoscopy. As a result, pneumatic otoscopy is rarely performed and even, more importantly, rarely performed accurately. There have been attempts at pneumatic-specific specula tips, such as the SofSeal and SofSpec from Welch Allyn, but these products do not seal the ear canal significantly better than standard tips, which explain the poor adoption of the SofSeal specula by physicians. The SofSeal uses a hard rubber, which does not seal well with the ear canal.
Correct performance and evaluation of a pneumatic otoscope exam alongside a traditional otoscope exam increases diagnostic accuracy of otitis media (OM) from 50% to better than 90% amongst experienced users, and it is the strongest diagnostic recommendation from AAP and AAO for OM. Despite this strong recommendation from the guideline providers, less than 50% of physicians utilize pneumatic otoscopy as part of their normal patient exam, and 43% of pneumatic otoscope exams are performed or interpreted incorrectly. The biggest reason for the poor adoption and use of this technique is the difficulty associated with obtaining a seal of the ear canal. Sealing the ear canal is currently a requirement to perform pneumatic otoscopy, and it can be very difficult to achieve with current tools and in the presence of uncooperative pediatric patients. The present invention attempts to solve these problems, as well as others.